SUPAC-IR/MR
This article was originally published in The Tan Sheet
Executive Summary
FDA announces availability of industry guidance entitled "SUPAC-IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms, Manufacturing Equipment and Addendum." The guidance for NDA and ANDA sponsors who "wish to change equipment during the postapproval period" is available at www.fda.gov/cder/guidance/index.htm